Label: BERKLEY JENSEN INSTANT HAND SANITIZER- ethyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 16, 2020

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  • Active ingredient

    Ethyl Alcohol 65%

    Purpose

    Antiseptic

  • Uses

    to help reduce bacteria on the skin.

  • Warnings

    • For external use only
    • Flammable
    • Keep away from source of heat or fire.

    When using this product

    avoid contact with eyes. If contact occurs, rinse with water.

    Stop using this product and ask doctor if 

    irritation or redness develops and lasts.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    wet hands thoroughly and rub together until dry.

  • Other information

    store at a temperature below 110°F (43°C)

  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

  • Questions or comments?

    1-800-934-1204

  • Label Copy 2 fl oz

    image of the label 2 oz

  • Label Copy 12 fl oz

    image of the label 12 oz

  • INGREDIENTS AND APPEARANCE
    BERKLEY JENSEN INSTANT HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68391-168
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL650 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68391-168-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
    2NDC:68391-168-08354 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/13/2020
    Labeler - BJWC (159082692)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(68391-168)
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